Latest updates for INCY PCYC SGEN BMRN CEMP CYTK CYTR EBIO EXEL KYTH LPCN LXRX MDCO NBIX NBS OCRX OGXI OPK THLD THRX TSRO

May 02, 2015 No Comments by

Latest updates to the Company Pipeline Database for April 29-May 1 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary INCY 98.28 Ruxolitinib – JANUS 1 and JANUS 2 Cancer – Pancreatic Phase 3 Phase 3 data for JANUS 1 due 2016. JANUS 2 due at a later date PCYC 254.51 IMBRUVICA […]

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Updates for ADHD AKBA CYTR OCUL RDUS TBPH VSTM

Mar 11, 2015 No Comments by

Latest updates to the Company Pipeline Database. Refer to the FDA Calendar for upcoming catalysts: ADHD 7.12 MDX (Metadoxine Extended Release (MG01CI)) Pediatric ADHD Phase 2b Phase 2b data released March 2015. No safety concerns but analyses of secondary cognitive measures did not produce statistically significant results 3/11/2015 AKBA 11.43 AKB-6548 Anemia related to chronic […]

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CYTR and MDVN release clinical data. ALXA initiates Phase 2 trial

Jan 22, 2015 No Comments by

Latest updates to the Company Pipeline Database for January 22, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ALXA 2.07 AZ-002 Acute repetitive seizures Phase 2 Phase 2 initiated late Jan 2014 1/23/2015 CYTR 3.01 Aldoxorubicin Cancer – soft tissue sarcomas first line Phase 2b Overall […]

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Distinct lack of clinical news this week – updates for OCUL and CYTR

Jan 22, 2015 No Comments

There has been a noticeable lack of major clinical news over the last couple days following the JPM Conference last week and looking forward to the 4Q earnings season in a couple weeks. Latest updates to the Company Pipeline Database from January 20 and 21, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker […]

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NBIX meets Phase 3 endpoint + updates for ALNY CNAT CYTR PLX GALE GWPH INFI IXPL KMDA LGND OTIC RGLS SGYP VSAR VSTM

Jan 09, 2015 No Comments

Latest updates to the Company Pipeline Database from January 8, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Text Updated ALNY 101.70 Patisiran APOLLO Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR Phase 3 Phase 3 trial initiated Nov 2013, continues to enrol patients as of Nov 2014. Expects […]

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KBIO Phase 2 trial failure. CNAT data due this week + updates for ARIA CANF RARE TNXP TRVN AKBA BCLI CEMP CYTR MSTX RVNC RLYP GEVA

Jan 07, 2015 No Comments

Latest updates to the Company Pipeline Database from January 5 and 6, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Link Text Updated ARIA 6.51 Iclusig (ponatinib) Cancer – refractory chronic-phase chronic myeloid leukemia (CP-CML) Phase 2 Phase 2 dose ranging trial to be initiated mid 2015 1/7/2015 CANF […]

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QRXPY Adcom date set. RMTI submits NDA. ARIA and CYTR initiate pivotal trials.

Mar 25, 2014 No Comments

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced that the FDA has set 22 April 2014 as the date of the Advisory Committee meeting to consider the resubmitted Moxduo New Drug Application (NDA). The PDUFA date is 25 May, 2014. Rockwell Medical, Inc. (Nasdaq:RMTI)  announced the submission of a New Drug Application (NDA) to the FDA for Triferic (soluble […]

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VNDA FDA Approval. IMGN Phase 3 data release update. RGDO and MELA private placements + CYTR prices offering

Feb 02, 2014 No Comments

Vanda Pharmaceuticals Inc.(VANDA) (NASDAQ: VNDA) announced that the FDA has approved HETLIOZ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).  HETLIOZ is the first FDA approved medication for Non-24. Regado Biosciences, Inc. (Nasdaq: RGDO) announced that it will sell $20 million of its common stock in a private placement. They also noted that the second interim analysis of REGULATE-PCI […]

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AVNR files NDA. AVEO discontinues BATON trial. CORT date due 2Q. CYTR offering. SLXP PDUFA set + AERI GERN

Jan 31, 2014 No Comments

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that they have submitted a New Drug Application (NDA) to the FDA for AVP-825, for the acute treatment of migraine. AVEO Oncology (NASDAQ: AVEO $1.67)  announced that AVEO and Astellas Pharma Inc. have jointly decided to discontinue the BATON (Biomarker Assessment of Tivozanib in ONcology) breast cancer Phase 2 trial due to insufficient enrollment. Aerie Pharmaceuticals, Inc. (NASDAQ:AERI $17.91) announced dosing […]

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BDSI ENDP Phase 3 endpoint met. PGNX ATOS TXNP DSCI to raise cash. EXEL XNPT price offerings. APPA NASDAQ uplist + CYTR

Jan 24, 2014 No Comments

Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) filed a $150m shelf and also noted that it has entered into a sales agreement where up to $50m of common stock may be issued and sold under a sales agreement with Cantor Fitzgerald & Co. Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) announced that it intends to offer shares of its common stock in an […]

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CHTP wins at Adcom + updates for MEIP MNOV BMRN CYTR NKTR CTIC NYMX

Jan 15, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $2.30) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic […]

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